Analyte concentration determination in physiological samples is of ever increasing importance to today's society. Such assays find use in a variety of application settings, including clinical laboratory testing, home testing, etc., where the results of such testing play a prominent role in the diagnosis and management of a variety of disease conditions. Analytes of interest include glucose for diabetes management, cholesterol for monitoring cardiovascular conditions, and the like. In response to this growing importance of analyte concentration determination, a variety of analyte concentration determination protocols and devices for both clinical and home testing have been developed.
Before testing can begin, an individual seeking to determine the presence and/or concentration of an analyte in a physiological sample must first obtain a test strip, apply a sample thereto and obtain the results either manually or automatically with a meter or the like. However, obtaining a test strip to begin the procedure is not without difficulty. The ability to easily obtain a test strip, particularly a single test strip from amongst a plurality of test strips is important particularly for those containers and test strips that will be used by persons with diminished hand-eye coordination or finger sensation. For example, persons with diabetes typically have either or both impaired vision and diminished finger sensation or other dexterity problems. Such persons must use test strips to test their blood glucose levels a number of times a day. However, the typical test strip is only several millimeters in width and length and, thus, difficult to manipulate.
The simplest test strip containers are simple storage reservoirs where the test strips are retained inside and manually removed. However, it is difficult to easily extract a test strip from these containers. These containers are usually shaped and sized to hold a plurality of test strips and to completely encompass the test strips inside so as to protect the test strips from light, humidity, and other environmental contaminants including oils and the like from an individual's hands, where such protection is necessary to insure the precision, accuracy and overall integrity of the test result.
An exemplary embodiment of such a simple test strip container is shown in FIG. 1. To obtain a single test strip from the container to begin a test, an individual has two options for removing a test strip. In one option, an individual may simply turn the container upside down to pour a test strip out. This, as is apparent, has significant disadvantages as one or all of the test strips stored inside the container may quickly spill out and become contaminated or damaged. In a second option, an individual places a finger inside the container to try to grasp a single test strip amongst a plurality of test strips without damaging or contaminating any of the strips in the process. However, such a method is difficult for individuals who have either or both impaired vision and diminished finger sensation and oftentimes results in an individual inadvertently contacting portions of the test strip that should not be touched, such as testing or reaction areas (i.e., areas on the strip having testing reagents, etc.) and the like, where such contact can impart contaminants and cause erroneous testing results. Similarly, other test strips may be inadvertently contacted resulting in erroneous testing results of those test strips as well. Furthermore, the container must have a suitable shape and a large enough size to accommodate at least one finger therein for easy removal of a test strip. In other words, the container must enable an individual, i.e., an individual who may be visually and/or dextrally impaired, to retrieve a test strip from amongst a plurality of test strips without damaging or contaminating any of such test strips.
It can be appreciated that the container, while maintaining a size large enough to serve its functions, must be small enough to enable portability of the container so that an individual may easily carry the container at all times to accommodate testing during the course of a day. Due to the above described shape and size requirements, conventional containers are typically cylindrical, i.e., have a circular cross-sectional shape, to accommodate insertion of at least one finger therein, and have a height of about 60 mm and a diameter of about 25 mm and are commercially sold with about 25 test strips retained therein. Such size and shape creates a great amount of unused space inside the container, minimizes the portability of the container and adds to the container's costs. In other words, the containers are larger than necessary to simply hold the test strips, thus increasing costs and decreasing portability.
More complex test strip containers have been developed to try to overcome some of the disadvantages associated with the simple test strip containers described above (see for example U.S. Pat. Nos. 5,575,403, 5,489,414; 5,630,986; 5,510,266). However, these, too, have certain disadvantages. For example, these devices often require a degree of physical dexterity and visual acuity that may be lacking in certain individuals who use the containers. Also, due to the complexity of the devices, i.e., the numbers of components forming the containers, the cost of manufacture increases and thus the cost to the user increases.
As such, there is continued interest in the development of new devices and methods for use in test strip dispensing. Of particular interest would be the development of such devices and methods which are easy and inexpensive to manufacture, have minimal components, are easy to use, particularly for visually and dextrally impaired individuals, are portable and which minimize damage and/or contamination to the test strips contained therein.